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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS PLATINUM 10 CONCEN W/SENS O2 9153642105 GENERATOR, OXYGEN, PORTABLE

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INVACARE FLORIDA OPERATIONS PLATINUM 10 CONCEN W/SENS O2 9153642105 GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number IRC10LXO2
Device Problems Power Switch; Compressor (Air Pump); Concentrator; Device Alarm System
Event Type  Malfunction  
Event Description

It was reported by provider that the compressor is loud and squeaking on the irc10lxo2 concentrator. Provider also advised the power switch is causing no alarm. 11,273 hours on unit.

 
Manufacturer Narrative

Follow up wil be filed if additional information is received.

 
Manufacturer Narrative

The device was returned however, it was unable to test.

 
Event Description

It was reported by provider that the compressor is loud and squeaking on the irc10lxo2 concentrator. Provider also advised the power switch is causing no alarm. 11,273 hours on unit.

 
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Brand NamePLATINUM 10 CONCEN W/SENS O2 9153642105
Type of DeviceGENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
INVACARE FLORIDA OPERATIONS
2101 east lake mary blvd
sanford FL 32773
Manufacturer (Section G)
INVACARE FLORIDA OPERATIONS
2101 east lake mary blvd
sanford FL 32773
Manufacturer Contact
kevin guyton
one invacare way
elyria , OH 44035
8003336900
MDR Report Key4928265
Report Number1031452-2015-14986
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type Distributor,DISTRIBUTOR
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup
Report Date 07/20/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/21/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberIRC10LXO2
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/20/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2015
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 07/21/2015 Patient Sequence Number: 1
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